5. Colposcopist performing exam: (Draw SCJ, acetowhite, punctation, mosaics, atypical vessels, and other lesions)

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1 Appendix 1 Colposcopy record 1. Medical Record Number: 2. Patient s Name: EXAMPLE 3. Age: 4. Date of visit: / / (Day/Month/Year) 5. Colposcopist performing exam: 6. Did you see the entire suamocolumnar junction (SCJ)? Yes No (If No, consider endocervical curettage) 7. Unsatisfactory colposcopy: Entire SCJ not visualised Entire lesion not visualised 8. Colposcopic findings within the transformation zone (use to indicate result): (Draw SCJ, acetowhite, punctation, mosaics, atypical vessels, and other lesions) Flat acetowhite epithelium Micropapillary or microconvoluted acetowhite epithelium Leukoplakia Punctation Mosaic Atypical vessels Iodine- negative epithelium Other, specify: 9. Findings outside the transformation zone: 10. Colposcopically suspect invasive carcinoma: Yes No 11. Miscellaneous findings: 12. Colposcopic diagnosis (use to indicate result): Unsatisfactory, specify: Normal colposcopic findings Inflammation/infection, specify: 121

2 Appendix Leukoplakia Condyloma Low-grade CIN High-grade CIN Invasive cancer, specify location of referral: Other, specify: Number of biopsies taken (mark site(s) with an X on colposcopy drawing) Endocervical curettage (ECC) taken 13. Other findings (use to indicate all that apply): Lesion extended into endocervix Mucosal bleeding easily induced Purulent cervicitis Opaue discharge Yellow discharge Other, specify: 14. Colposcopist s signature: 15. If test performed at colposcopy exam, note results below: Cytology result: ECC result: Biopsy result: Negative Negative Negative Atypia/CIN 1 CIN 1 CIN 1 CIN 2 CIN 2 CIN 2 CIN 3 CIN 3 CIN 3 Invasive cancer Microinvasive suamous cancer Microinvasive suamous cancer Invasive suamous cancer Adenocarcinoma Glandular dysplasia Invasive suamous cancer Adenocarcinoma in-situ Adenocarcinoma ECC not done 122

3 Appendix 2 Consent form Patient s Name.. Health Center. EXAMPLE Consent for Colposcopy, Biopsy, and Possible Treatment Cervical cancer is a problem for women in our region, but much of it could be prevented by simple tests. The clinicians here are using a test that can find problems early. If these problems are found early, they can be treated easily and cancer can be avoided. Procedures You were referred for colposcopy because there is a possible problem with your cervix. If you decide to participate in this examination, the clinician will provide counselling and education about cervical cancer, ask you some uestions about your reproductive history and risk of being pregnant, and examine your cervix today. S/he will use a speculum to hold the vagina open. Then, s/he will gently wipe your cervix with vinegar. You may feel a slight stinging from the vinegar. The clinician will look at your cervix with a colposcope, which magnifies and illuminates the cervix to help the clinician see your cervix more clearly. The colposcope will not touch your body. The examination will take about 5 to 7 minutes. If the examination with the colposcope shows that your cervix is healthy, you will be finished with your examination. If the examination with the colposcope shows that your cervix is not healthy, the clinician will take a small sample of tissue from your cervix (this is called a biopsy) in order to check the diagnosis. The biopsy may cause some pain that lasts a few seconds and varies from mild pinching to some cramping sensations. After the biopsy, you will be treated with cryotherapy to remove the area that is a problem on your cervix. You will probably feel some cramping during and after the procedure; the cramping usually stops shortly after the procedure. You also will probably experience spotting or light bleeding from your cervix for 1 to 2 weeks and a watery vaginal discharge that lasts 2 to 4 weeks. You will be asked to not have sexual intercourse for 3 to 4 weeks to allow your cervix to heal properly. You also will be asked to return to the clinic 9-12 months after the procedure for a follow-up visit. The clinician will look at your cervix again with a colposcope in order to make sure that the treatment was successful. If, however, the colposcopic examination shows that the treatment was not successful, you will be advised on further steps to take. Risks You may be embarrassed by the vaginal examination. The colposcopy examination may cause vaginal irritation and burning for several minutes. You may experience slight vaginal bleeding for one or two days if a biopsy is taken from your cervix. You may experience a watery vaginal discharge for up to four weeks if you undergo treatment by cryotherapy. Although it is unlikely, you also may experience heavy vaginal bleeding. There is a 10% risk that cryotherapy, if used correctly, will not be effective, but this outcome will be detected at the follow-up examination after 9-12 months. Eligibility Before being examined, you will be asked a series of uestions to determine if there is a chance of your being pregnant. If so, you will be tested with a standard urine pregnancy test. You will be examined using colposcopy 123

4 Appendix regardless of your pregnancy status. If you reuire treatment and the pregnancy test is positive, your treatment will be postponed until six weeks after delivery. Confidentiality All of your personal information will be kept confidential and used only for your medical care. Any other use will reuire your written consent. If you refuse any part of this examination, it will not affect care that we give you in the future. Questions Please direct any uestions you have about the examination or your rights as a patient to district hospital staff. Patient Statement (Provider s copy) The information above on colposcopy, biopsy, and possible treatment has been explained to me and I have been given the opportunity to ask uestions. I agree to participate in this examination. Signature of patient OR thumbprint of patient Date Signature of witness Date (tear off at dotted line and give to patient) Patient Statement (Patient s copy) The information above on colposcopy, biopsy, and possible treatment has been explained to me and I have been given the opportunity to ask uestions. I agree to participate in this examination. Signature of patient OR thumbprint of patient Date Signature of witness Date 124

5 Appendix 3 Preparation of 5% acetic acid, Lugol s iodine solution, and Monsel s paste 5% dilute acetic acid Ingredients Quantity 1. Glacial acetic acid 5 ml 2. Distilled water 95 ml Preparation Carefully add 5 ml of glacial acetic acid into 95 ml of distilled water and mix thoroughly. Storage: Unused acetic acid should be discarded at the end of the day. Label: 5% dilute acetic acid Note: It is important to remember to dilute the glacial acetic acid, since the undiluted strength causes a severe chemical burn if applied to the epithelium. Lugol s iodine solution Ingredients Quantity 1. Potassium iodide 10 g 2. Distilled water 100 ml 3. Iodine crystals 5 g Preparation A. Dissolve 10 g potassium iodide in 100 ml of distilled water. B. Slowly add 5 g iodine crystals, while shaking. C. Filter and store in a tightly stoppered brown bottle. Storage: 1 month Label: Lugol s iodine solution Use by (date) 125

6 Appendix Monsel s paste Ingredients Quantity 1. Ferric sulfate base 15 g 2. Ferrous sulfate powder a few grains 3. Sterile water for mixing 10 ml 4. Glycerol starch (see preparation on next page) 12 g Preparation Take care: The reaction is exothermic (emits heat). A. Add a few grains of ferrous sulfate powder to 10 ml of sterile water in a glass beaker. Shake. B. Dissolve the ferric sulfate base in the solution by stirring with a glass stick. The solution should become crystal clear. C. Weigh the glycerol starch in a glass mortar. Mix well. D. Slowly add ferric sulfate solution to glycerol starch, constantly mixing to get a homogeneous mixture. E. Place in a 25 ml brown glass bottle. F. For clinical use, most clinics prefer to allow enough evaporation to give the solution a sticky pastelike consistency that looks like mustard. This may take 2 to 3 weeks, depending on the environment. The top of the container can then be secured for storage. If necessary, sterile water can be added to the paste to thin it. Note: This preparation contains 15% elementary iron. Storage: 6 months Label: Monsel s solution Shake well External use only Use by (date) Glycerol starch (an ingredient in Monsel s paste) Ingredients Quantity 1. Starch 30 g 2. Sterile water for mixing 30 ml 3. Glycerine 390 g Preparation A. In a china crucible, dissolve the starch in the sterile water. B. Add the glycerine. Shake well. C. Heat the crucible and its contents over a bunsen burner. Mix constantly with a spatula until the mass takes on a thick, swelling consistency. Take care not to overheat so as not to let it turn yellow. Storage: 1 year Label: Glycerol starch Store in a cool place For external use only Use by (date) Note: Do not overheat, otherwise the mixture will turn yellow. 126

7 Appendix 4 Colposcopic terminology Normal colposcopic findings Original suamous epithelium Columnar epithelium Normal transformation zone Abnormal colposcopic findings Within the transformation zone Acetowhite epithelium Flat Micropapillary or microconvoluted Punctation* Mosaic* Leukoplakia* Iodine-negative epithelium Atypical vessels Outside the transformation zone, e.g., ectocervix, vagina Acetowhite epithelium* Flat Micropapillary or microconvoluted Punctation* Mosaic* Leukoplakia* Iodine-negative epithelium Atypical vessels Colposcopically suspect invasive carcinoma Unsatisfactory colposcopy Suamocolumnar junction not visible Severe inflammation or severe atrophy Cervix not visible Miscellaneous findings Nonacetowhite micropapillary surface Exophytic condyloma lnflammation Atrophy Ulcer Other * Indicates minor or major change. Minor changes are acetowhite epithelium, fine mosaic, fine punctation, and thin leukoplakia. Major changes are dense acetowhite epithelium, coarse mosaic, coarse punctation, thick leukoplakia, atypical vessels, and erosion. Ref: Stafl and Wilbanks (1991) 127

8 Appendix 5 The modified Reid colposcopic index (RCI)* The modified Reid colposcopic index (RCI)* Colposcopic signs Zero point One point Two points Colour Low-intensity acetowhitening (not Intermediate shade Dull, opaue, completely opaue); indistinct - grey/white colour oyster white; grey acetowhitening; transparent or and shiny surface translucent acetowhitening (most lesions should Acetowhitening beyond the margin of be scored in this the transformation zone category) Pure snow-white colour with intense surface shine (rare) Lesion margin and surface Microcondylomatous or micropapillary contour 1 Regular-shaped, symmetrical lesions Rolled, peeling edges 2 configuration Flat lesions with indistinct margins with smooth, Internal Feathered or finely scalloped margins Angular, jagged lesions 3 straight outlines demarcations between areas of Satellite lesions beyond the margin of differing the transformation zone colposcopic appearance a central area of high-grade change and peripheral area of low-grade change Vessels Fine/uniform-calibre vessels 4 - closely Absent vessels Well defined coarse and uniformly placed punctation or Poorly formed patterns of fine mosaic, sharply punctation and/or mosaic demarcated 5 and Vessels beyond the margin of the randomly and transformation zone widely placed Fine vessels within microcondylomatous or micropapillary lesions 6 128

9 Appendix The modified Reid colposcopic index (RCI)*(Cont.) Colposcopic signs Zero point One point Two points Iodine staining Positive iodine uptake giving mahogany- Partial iodine Negative iodine brown color uptake - variegated, uptake of Negative uptake of insignificant lesion, speckled significant lesion, i.e., yellow staining by a lesion scoring appearance i.e., yellow staining three points or less on the first three by a lesion already criteria scoring four points Areas beyond the margin of the or more on the first transformation zone, conspicuous on three criteria colposcopy, evident as iodine-negative areas (such areas are freuently due to parakeratosis) 7 * Colposcopic grading performed with 5% aueous acetic acid and Lugol s iodine solution. (See Appendix 3 for recipes for 5% acetic acid and for Lugol s iodine solution). 1 Microexophytic surface contour indicative of colposcopically overt cancer is not included in this scheme. 2 Epithelial edges tend to detach from underlying stroma and curl back on themselves. Note: Prominent low-grade lesions often are overinterpreted, while subtle avascular patches of HSIL can easily be overlooked. 3 Score zero even if part of the peripheral margin does have a straight course. 4 At times, mosaic patterns containing central vessels are characteristic of low-grade histological abnormalities. These lowgrade lesion capillary patterns can be uite pronounced. Until the physician can differentiate fine vascular patterns from coarse, overdiagnosis is the rule. 5 Branching atypical vessels indicative of colposcopically overt cancer are not included in this scheme. 6 Generally, the more microcondylomatous the lesion, the lower the score. However, cancer also can present as a condyloma, although this is a rare occurrence. 7 Parakeratosis: a superficial zone of cornified cells with retained nuclei. Colposcopic prediction of histologic diagnosis using the Reid Colposcopic Index (RCI) RCI (overall score) Histology 0 2 Likely to be CIN Overlapping lesion: likely to be CIN 1 or CIN Likely to be CIN

10 Index Acetowhitening , 59 65, 70, 81, 87, 128 Adenocarcinoma , 23, 72 Adenocarcinoma in situ , 19, 72 Adenosuamous carcinoma Anal intraepithelial neoplasia (AIN) Atypical suamous cells of undetermined significance (ASCUS) Atypical surface vessels Atypical transformation zone (ATZ) , 41 Bethesda system Blended cutting waveform Branching surface vessels , 48 Carcinoma in situ (CIS) , 14 Cervical intraepithelial neoplasia (CIN) , 55 68, Cervical stenosis , 111 Cervicitis Cervicovaginitis Coagulation waveform Coarse mosaic , 67, 87, 128 Coarse punctation , 63, 87, 128 Cold-knife conization , 92, 93, 110 Colposcope , 31 Colposcopic terminology Colposcopy record , 36, 121 Columnar epithelium , 48, 49, 53 Condyloma , 58, 92 Congenital transformation zone , 53 Consent form , 123 Cryotherapy (cryo) , Crypts , 10 Decontamination Dysplasia Ectocervix Ectopy , 8 Ectropion , 8 Endocervix , 3 Endocervical curettage (ECC)

11 Index Fine mosaic , 67, 87, 128 Fine puncuation , 67, 87, 128 Fulguration , 107 Glandular dysplasia High-grade suamous intraepithelial lesion (HSIL) High-level disinfection Histopathology , 24 Hyperkeratosis , 58, 92 Hyperplasia Immature metaplasia , International Federation of Gynaecology and Obstetrics (FIGO) staging system Inflammatory lesions , Keratinizing suamous cell carcinoma Leopard skin appearance Leukoplakia , 58, 86, 92 Loop electrosurgical excision procedure (LEEP) Low-grade suamous intraepithelial lesion (LSIL) Lugol s iodine solution , 41, 51, 65, 81, 125 Mature suamous metaplasia , 36, 51, 87 Microinvasive carcinoma Monsel s paste , 126 Nabothian cyst/follicle New suamocolumnar junction Non-keratinizing suamous cell carcinoma Pregnancy , Reid Colposcopic Index Reproductive tract infection Schiller s test (see also Lugol s iodine solution) Suamocolumnar junction (SCJ) , 87 Suamous metaplasia , Sterilization Stratified non-keratinizing suamous epithelium Transformation zone (TZ) , 53 54, 67, 87 Umbilication Vaginal intraepithelial neoplasia (VAIN) Visual inspection with acetic acid (VIA) , 41, 49, 59 65, 81, 87, 125 Visual inspection with acetic acid using magnification (VIAM) Vulvar intraepithelial neoplasia (VIN)

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